In a significant development for India’s pharmaceutical regulatory landscape, the Drugs Technical Advisory Board (DTAB) has reaffirmed its position to include all antimicrobial drugs under the definition of “New Drugs” as per the New Drugs and Clinical Trials Rules, 2019.
The decision was taken during the 93rd meeting of DTAB held on February 16, 2026, at FDA Bhawan, New Delhi, conducted in a hybrid format. The board reviewed and approved the Action Taken Report (ATR) from its previous (92nd) meeting held on April 24, 2025.